Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01860274
Other study ID # 00-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2015
Est. completion date June 28, 2020

Study information

Verified date March 2021
Source Cardiochirurgia E.H.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone. To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date June 28, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft - Coronary artery with critical stenosis (over 70%) Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
External Mesh for vein grafts


Locations

Country Name City State
Italy European Hospital Rome
Italy Mauriziano Hospital Turin

Sponsors (1)

Lead Sponsor Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patency Patency of graft at CT Scan 6 to 12 months
Secondary Major Adverse Cardiac and Cerebrovascular Events (MACCE) 60 months
Secondary Vein graft lumen uniformity 6 to 12 months
See also
  Status Clinical Trial Phase
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Recruiting NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Not yet recruiting NCT05366153 - Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer
Recruiting NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Not yet recruiting NCT04647448 - Multisensor Array for the Localisation of Coronary Artery Stenosis (MALCAS)
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT04562805 - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT) N/A
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Active, not recruiting NCT04483791 - DynamX Bioadaptor Hong Kong Registry Phase 4
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Completed NCT04375085 - DESyne X2 Post Market Follow-up Study N/A
Terminated NCT02528474 - Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents N/A